+44 (0)151 666 8999
3 months ago
£30,000- £35,000 dependant on experience, 25 days holiday plus bank holidays, 5% bonus and a relocation package of up to £8,000 is on offer.
Cheltenham, Chippenham, Swindon, Cirencester, South West, Wiltshire, Bath
A well known Pharmaceutical CMO is currently seeking a permanent QA Officer. The QA Officer will be responsible for implementing quality systems and related processes from project phase (equipment and process validation) to full cGMP commercialization for one of the businesses clients. Whilst reporting into the QA Team Leader.
The QA Officer duties will be varied, however the key duties and responsibilities will be to provide QA oversight to operational activities taking place within the assigned business unit by:
- Working closely with Production and Engineering to ensure new products are manufactured in accordance with cGMP.
- Providing Quality Input on the life cycle of Validation documents from URS’s through to PQ’s
- Implementing QA on the shop floor; reviewing sterilization cycles, FMS systems and cleanroom logbooks
- Providing quality and compliance input in reviewing of Batch Manufacturing Record Reviews, CAPA’s & Deviations, Complaints & OOS across departments.
- Review and update of Standard Operating Procedures and Controlled Documents as required.
- Working closely with the site Qualified Persons (QPs) ensuring batch release schedules are adhered to.
- Closure of batch records with associate LIMS & SAP transactions & C of A generation.
- Local area & local system audits.
- Media fill observation, reading & report writing
- Providing annual product reviews for our client’s product.
- Participation in investigating customer complaints.
- Cleanroom opening support (requalification of equipment & services).
- Science based degree.
- Proven industry experience with a minimum of 2 years in a Quality Assurance Pharmaceutical manufacturing environment.
- Experience of working in a sterile manufacturing facility would be advantageous.
- Potential involvement in the set-up of a new facility or process..
In return you will receive a very competitive salary and benefits package combined with up to £8,000 relocation assistance if necessary.
To apply please submit your CV
Scantec Personnel Limited is acting as an employment business and an employment agency. For contract or interim roles (and unless otherwise stated), all pay rates stated are on a Limited Company basis.
Due to the high volume of applications Scantec receives it is not always possible to acknowledge every application. Shortlisted applicants will be contacted within 28 days. If you don’t hear from us within 28 days your application has not been shortlisted at this time, to be considered for future vacancies please register with us on our website.